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RECRUITING Not applicable ClinicalTrials.gov

Sleep and Arterial Function in Hypertensive Patients With Poor Sleep Quality

Sponsor: Unidade Local de Saúde do Alto Ave, EPE • ClinicalTrials.gov ID: NCT07789535

Registry updated: 2026-08-27
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Description

This prospective, parallel-group randomised controlled trial evaluates whether cognitive-behavioural therapy for insomnia (CBT-I) improves arterial function and psychological and cognitive outcomes in hypertensive patients with poor sleep quality. Adults aged 18-70 with controlled hypertension and poor baseline sleep quality (sleep efficiency \<=85%) are randomised 1:1 to CBT-I (four weekly 60-minute sessions) or passive sleep education. The primary outcomes are change from baseline in pulse wave velocity and central arterial pressure at 12 months. Secondary outcomes include blood pressure, depressive symptoms, perceived stress, cognitive complaints, and sleep quality, assessed at baseline, 1, 6, and 12 months.

Interventions

  • Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I) (Behavioral)
    Cognitive-behavioural therapy for insomnia delivered in four weekly 60-minute sessions, incorporating sleep hygiene, stimulus control, and relaxation techniques. Based on baseline polysomnography, the protocol is adapted for participants without obstructive sleep apnea, with mild obstructive sleep apnea, or with comorbid insomnia and mild sleep apnea (COMISA).
  • Passive sleep education (Behavioral)
    Passive sleep education consisting of informational leaflets plus non-interactive follow-up calls. Participants in this control condition are offered access to CBT-I after study completion.

Eligibility criteria

Inclusion Criteria: * Adults aged 18 to 70 years * Controlled hypertension * Poor baseline sleep quality (sleep efficiency \<=85% assessed via actigraphy or type II polysomnography) * Capable of providing informed consent * Participants with mild obstructive sleep apnea (apnea-hypopnea index 5-14.9/h on type II polysomnography) who do not meet criteria for CPAP/PAP therapy are eligible Exclusion Criteria: * Severe cardiovascular disease (e.g., acute myocardial infarction or stroke) * Severe neurological diseases * Moderate-to-severe obstructive sleep apnea (AHI \>=15/h) or any obstructive sleep apnea with an indication for CPAP/PAP therapy * Central disorders of hypersomnolence * Intellectual disability * Pregnancy

Conditions

Hypertension Poor Sleep Quality Insomnia Arterial Stiffness

Locations

  • Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira — Guimarães, Braga District, Portugal
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record